Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis
- Conditions
- Allergic RhinitisAsthma
- Interventions
- Registration Number
- NCT01963741
- Lead Sponsor
- Guangzhou Institute of Respiratory Disease
- Brief Summary
Leukotrienes play critical roles in the inflammatory process in allergic rhinitis and bronchial asthma, therefore, anti-leukotriene therapy is part of treatment for asthma. However, not all allergic rhinitis accompanied with or without asthma treated with anti-leukotriene were effective. So it is critical to develop a method to identify the response subgroup. In this study, it is assumed that nasal physiological responsiveness to leukotriene nasal provocation test (NPT) is able to gain evidence on the effect of leukotriene on the development of allergic rhinitis and asthma, and is helpful to the use of anti-leukotriene agent. The purpose of the study is to establish the methodology and diagnostic value of leukotriene D4 (LTD4) nasal provocation.
- Detailed Description
Nasal provocation test induced by LTD4 will be conducted by measuring nasal airway resistance and airway symptoms in a stepwise concentration of LTD4 by nasal spray. Inflammation biomarkers, such as eosinophilic granulocyte in sputum and nasal lavage, fractional exhaled nitric oxide(FeNO), and lung function before and after nasal provocation will be studied to explore the impact of LTD4 nasal provocation test on airway inflammation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients with allergic rhinitis accompanied with or without asthma
- positive skin prick test (SPT)
- had no acute upper or lower airway infection 2 weeks prior to study
- no oral or nasal anti-histamines
- no leukotriene receptor antagonists for 1 week
- no oral or nasal and inhaled corticosteroids for 2 weeks
- smokers
- a past confirmed history of chronic respiratory disease other than asthma
- other severe systemic diseases (myocardial infarction, malignant tumor, etc.)
- under immunotherapy
- unable to complete the test or had limited understanding
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description leukotriene D4 histamine Nasal provocation test was induced by leukotriene D4 with a stepwisely concentration method (4 mcg/ml, 8 mcg/ml, 16 mcg/ml). histamine leukotriene D4 Nasal provocation test was induced by histamine with a stepwisely concentration method (0.4 mg/ml, 0.8 mg/ml, 1.6 mg/ml, 3.2mg/ml).
- Primary Outcome Measures
Name Time Method Percentage of participants positive response to leukotriene D4 or histamine nasal provocation test Until 1 hour after the nasal provocation test Nasal airway resistance measured by positive anterior rhinomanometry. Concentration induced 60% increase of nasal airway resistance (PC60-NAR) will be measured and reported; Composite symptoms score defined by reichmann H and his colleagues showed as follows:3-5 sneezes = 1 point (pt), \>5 sneezes = 2 points (pts); rhinorrhoea \< 1 milliliter (mL) = 1 pt, rhinorrhoea \> 1 milliliter = 2 pts; pruritus of the palate or ear or eye= 1 pt, conjunctivitis or cough or urticaria or difficult breathing= 2 pts. Total score ranges from 0 to 6 pts. Positive response to LTD4 nasal provocation test was defined as PC60-NAR less than 16mcg/mL or the symptom score higher than 3.
- Secondary Outcome Measures
Name Time Method Change from baseline of eosinophils in sputum and nasal lavage and fractional exhaled nitric oxide (FeNO) 4 and 24 hours after the nasal provocation test Biomarkers in upper and lower airways such as eosinophils in sputum and nasal lavage and fractional exhaled nitric oxide (FeNO) will be studied.
Trial Locations
- Locations (1)
Guangzhou institute of respiratory disease
🇨🇳Guangzhou, Guangdong, China